HR 2090 · 109th Congress · Health
Food and Drug Administration Improvement Act of 2005
Bill Progress
✓
Introduced2
Committee3
House Vote4
Senate5
EnactedLatest: Sponsor introductory remarks on measure. (CR H4358-4359)(2006-06-21)
Plain Language Summary
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Food and Drug Administration Improvement Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require that all fees collected for the review of applications for human drugs, devices, and animal drugs be deposited in the general fund of the Treasury. Makes available amounts necessary for the Secretary of Health and Human Services to review such applications. Prohibits the Secretary from entering into agreements with persons from whom such fees are collected and terminates any existing agreements. Requires the Secretary to: (1) establish the Center for Postmarket Drug Safety and Effectiveness within the Food and Drug Administration (FDA) to regulate approved drugs; and (2) transfer to the Center all responsibilities for such regulation from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. Allows the Secretary to require manufacturers of approved drugs to conduct studies of an identified significant safety issue with the drug. Deems a drug to be misbranded if it does not meet the Secretary's requirements, including requirements for labeling and conducting postmarket studies. Requires the Secretary to follow the inter…
Summarized by Claude AI · Non-partisan · For informational purposes only
Cosponsors (15)
14 Democrats1 Independent